Risk of disease relapse, safety and tolerability of SARS-CoV-2 vaccination in patients with chronic inflammatory neuropathies

Pietro Emiliano Doneddu^{1

2}, Chiara Briani³, Dario Cocito⁴, Fiore Manganelli⁵, Gian Maria Fabrizi⁶, Sabrina Matà⁷, Anna Mazzeo⁸, Raffaella Fazio⁹, Luana Benedetti¹⁰, Marco Luigetti^{11

12}, Maurizio Inghilleri¹³, Elisa Ruiu¹⁴, Gabriele Siciliano¹⁵, Giuseppe Cosentino^{16

17}, Girolama Alessandra Marfia¹⁸, Marinella Carpo¹⁹, Massimiliano Filosto²⁰, Giovanni Antonini²¹, Francesca Notturno²², Stefano Sotgiu²³, Laura Cucurachi²⁴, Claudia Dell'Aquila²⁵, Elisa Bianchi²⁶, Tiziana Rosso²⁷, Andrea Giordano¹, Marco Fernandes¹, Marta Campagnolo³, Erdita Peci⁴, Emanuele Spina⁵, Matteo Tagliapietra⁶, Martina Sperti⁷, Luca Gentile⁸, Camilla Strano⁹, Francesco Germano¹⁰, Marina Romozzi^{11

12}, Federica Moret¹³, Ignazio Roberto Zarbo^{14

28}, Divina Valeria Viola¹⁵, Elisa Vegezzi¹⁶, Giorgia Mataluni¹⁸, Stefano Cotti-Piccinelli²⁰, Luca Leonardi²¹, Alessandra Carta²³, Eduardo Nobile-Orazio^{1

29}; INCLUSIVE Study Group

Affiliations

¹ Neuromuscular and Neuroimmunology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
² Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
³ Neurology Unit, Department of Neuroscience, University of Padova, Padova, Italy.
⁴ SSD Patologie Neurologiche Specialistiche, AOU San Luigi, Torino, Italy.
⁵ Department of Neuroscience, Reproductive Sciences and Odontostomatology, University of Naples 'Federico II', Naples, Italy.
⁶ Department of Neuroscience, UOC Neurology B, University Hospital GB Rossi, AOUI and University of Verona, Verona, Italy.
⁷ Department of Neurological and Psychiatric Sciences, Azienda Ospedaliero-Universitaria di Careggi, Florence, Italy.
⁸ Unit of Neurology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
⁹ Division of Neuroscience, Department of Neurology, Institute of Experimental Neurology (INSPE), San Raffaele Scientific Institute, Milan, Italy.
¹⁰ IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
¹¹ Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurologia, Rome, Italy.
¹² Università Cattolica del Sacro Cuore, Sede di Roma, Rome, Italy.
¹³ Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
¹⁴ Neurology Unit, Azienda Ospedaliera Universitaria di Sassari, Sassari, Italy.
¹⁵ Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
¹⁶ IRCCS Mondino Foundation, Pavia, Italy.
¹⁷ Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
¹⁸ Dysimmune Neuropathies Unit, Department of Systems Medicine, Tor Vergata University of Rome, Rome, Italy.
¹⁹ ASST Bergamo Ovest-Ospedale Treviglio, Treviglio, Italy.
²⁰ Department of Clinical and Experimental Sciences, NeMO-Brescia Clinical Center for Neuromuscular Diseases, University of Brescia, Brescia, Italy.
²¹ Unit of Neurophysiopathology, Department of Neurology Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, 'Sapienza' University of Rome, Sant'Andrea Hospital, Rome, Italy.
²² Unit of Neurology, 'Floraspe Renzetti' Hospital, Lanciano, Italy.
²³ Child Neuropsychiatry Division, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
²⁴ U.O Neurologia, Ospedale "S. Chiara", Trento, Italy.
²⁵ Neurology Unit, Di Venere Hospital, Bari, Italy.
²⁶ Laboratorio di Malattie Neurologiche, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
²⁷ UOC di Neurologia, Ospedale San Bassiano, Bassano del Grappa, Vicenza, Italy.
²⁸ Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy.
²⁹ Department of Medical Biotechnology and Translational Medicine, Milan University, Milan, Italy.

PMID: 37000158
DOI: 10.1111/ene.15811

Multicenter Study

Risk of disease relapse, safety and tolerability of SARS-CoV-2 vaccination in patients with chronic inflammatory neuropathies

Pietro Emiliano Doneddu et al. Eur J Neurol. 2023 Jul.

. 2023 Jul;30(7):1907-1918.

doi: 10.1111/ene.15811. Epub 2023 Apr 11.

Authors

Affiliations

¹ Neuromuscular and Neuroimmunology Unit, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
² Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy.
³ Neurology Unit, Department of Neuroscience, University of Padova, Padova, Italy.
⁴ SSD Patologie Neurologiche Specialistiche, AOU San Luigi, Torino, Italy.
⁵ Department of Neuroscience, Reproductive Sciences and Odontostomatology, University of Naples 'Federico II', Naples, Italy.
⁶ Department of Neuroscience, UOC Neurology B, University Hospital GB Rossi, AOUI and University of Verona, Verona, Italy.
⁷ Department of Neurological and Psychiatric Sciences, Azienda Ospedaliero-Universitaria di Careggi, Florence, Italy.
⁸ Unit of Neurology, Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy.
⁹ Division of Neuroscience, Department of Neurology, Institute of Experimental Neurology (INSPE), San Raffaele Scientific Institute, Milan, Italy.
¹⁰ IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
¹¹ Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Neurologia, Rome, Italy.
¹² Università Cattolica del Sacro Cuore, Sede di Roma, Rome, Italy.
¹³ Department of Human Neurosciences, Sapienza University of Rome, Rome, Italy.
¹⁴ Neurology Unit, Azienda Ospedaliera Universitaria di Sassari, Sassari, Italy.
¹⁵ Neurology Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
¹⁶ IRCCS Mondino Foundation, Pavia, Italy.
¹⁷ Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
¹⁸ Dysimmune Neuropathies Unit, Department of Systems Medicine, Tor Vergata University of Rome, Rome, Italy.
¹⁹ ASST Bergamo Ovest-Ospedale Treviglio, Treviglio, Italy.
²⁰ Department of Clinical and Experimental Sciences, NeMO-Brescia Clinical Center for Neuromuscular Diseases, University of Brescia, Brescia, Italy.
²¹ Unit of Neurophysiopathology, Department of Neurology Mental Health and Sensory Organs (NESMOS), Faculty of Medicine and Psychology, 'Sapienza' University of Rome, Sant'Andrea Hospital, Rome, Italy.
²² Unit of Neurology, 'Floraspe Renzetti' Hospital, Lanciano, Italy.
²³ Child Neuropsychiatry Division, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
²⁴ U.O Neurologia, Ospedale "S. Chiara", Trento, Italy.
²⁵ Neurology Unit, Di Venere Hospital, Bari, Italy.
²⁶ Laboratorio di Malattie Neurologiche, Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
²⁷ UOC di Neurologia, Ospedale San Bassiano, Bassano del Grappa, Vicenza, Italy.
²⁸ Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy.
²⁹ Department of Medical Biotechnology and Translational Medicine, Milan University, Milan, Italy.

PMID: 37000158
DOI: 10.1111/ene.15811

Abstract

Background and purpose: The aim was to evaluate the risk of relapse after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, and its safety and tolerability, in patients with chronic inflammatory neuropathies.

Methods: In this multicenter, cohort and case-crossover study, the risk of relapse associated with SARS-CoV-2 vaccination was assessed by comparing the frequency of relapse in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) patients who underwent or did not undergo vaccination. Frequency of relapse in the 3 months prior to and after vaccination, and safety and tolerability of SARS-CoV-2 vaccination, were also assessed.

Results: In all, 336 patients were included (278 CIDP, 58 MMN). Three hundred and seven (91%) patients underwent SARS-CoV-2 vaccination. Twenty-nine patients (9%) did not undergo vaccination. Mild and transient relapses were observed in 16 (5%) patients (13 CIDP, 3 MMN) after SARS-CoV-2 vaccination and in none of the patients who did not undergo vaccination (relative risk [RR] 3.21, 95% confidence interval [CI] 0.19-52.25). There was no increase in the specific risk of relapse associated with type of vaccine or diagnosis. Comparison with the 3-month control period preceding vaccination revealed an increased risk of relapse after vaccination (RR 4.00, 95% CI 1.35-11.82), which was restricted to CIDP patients (RR 3.25, 95% CI 1.07-9.84). The safety profile of SARS-CoV-2 vaccination was characterized by short-term, mild-to-moderate local and systemic adverse events.

Conclusions: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in CIDP and MMN patients does not seem to be associated with an increased risk of relapse at the primary end-point, although a slightly increased risk in CIDP patients was found compared to the 3 months before vaccination.

Keywords: COVID-19; SARS-CoV-2; chronic inflammatory demyelinating polyneuropathy; multifocal motor neuropathy; vaccination.

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References

REFERENCES

1. Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ, et al. Guillain−Barré syndrome following vaccination in the National Influenza Immunization Program, United States, 1976-1977. Am J Epidemiol. 1979;110:105-123.
1. Tay SY, Chan WP. A 9-year-old female with bilateral leg weakness after influenza vaccination. Pediatr Ann. 2014;43:440-441.
1. Remiche G, Abramowicz M, Mavroudakis N. Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) associated to hereditary neuropathy with liability to pressure palsies (HNPP) and revealed after influenza AH1N1 vaccination. Acta Neurol Belg. 2013;113:519-522.
1. Gable KL, Afshari Z, Sufit RL, Allen JA. Distal acquired demyelinating symmetric neuropathy after vaccination. J Clin Neuromuscul Dis. 2013;14:117-122.
1. Brostoff JM, Beitverda Y, Birns J. Post-influenza vaccine chronic inflammatory demyelinating polyneuropathy. Age Ageing. 2008;37:229-230.

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Risk of disease relapse, safety and tolerability of SARS-CoV-2 vaccination in patients with chronic inflammatory neuropathies

Affiliations

Risk of disease relapse, safety and tolerability of SARS-CoV-2 vaccination in patients with chronic inflammatory neuropathies

Authors

Affiliations

Abstract

References

REFERENCES

Publication types

MeSH terms

Substances

LinkOut - more resources

Full Text Sources

Medical

Miscellaneous